Bioavailability and Pharmacodynamics of EPA and DHA From Fortified Soymilk and Capsules

Bioavailability and Pharmacodynamics of Eicosapentaenoic Acid and Docosahexaenoic Acid in Soymilk and Commercial Supplements

This study will compare the algae oil fortified soymilk to a commercial algae oil capsule containing the same base oil with the goal of demonstrating equivalent or greater accumulation of EPA and DHA in blood lipid pools.

Study Overview

• Status: Recruiting
• Conditions: Healthy Diet
• Intervention / Treatment: Other: Algae Oil Fortified Soymilk; Dietary supplement: Algae Oil Capsule

Detailed Description

Research shows that fish oil and its component fatty acids EPA and DHA provide health benefits such as reducing the risk of cardiac death and lowering inflammation. Yet a large portion of the population is not consuming the recommended amount of fish due to high cost, dietary restrictions such as vegetarianism/veganism, concerns about high levels of mercury, general dislike, and other factors. Additionally, to meet the recommendations fish and fish oil production present sustainability challenges. A potential alternative is to utilize EPA and DHA from algae. These sustainable oils can be added to foods increasing the potential for fatty acids to counteract chronic disease and increasing access to general consumers. Previously, our lab has developed, and optimized EPA and DHA fortified non-dairy plant milk beverages utilizing algae oil emulsions (food grade). Up to 0.4% algae oil can be added to soymilk with limited changes to overall liking. This study will compare the algae oil fortified soymilk to a commercial algae oil capsule containing the same base oil with the goal of demonstrating equivalent or greater accumulation of EPA and DHA in blood lipid pools. Subjects will consume either one beverage or two capsules per day, containing equivalent amounts of EPA and DHA. Blood will be taken at 4 time points throughout the 6 week study, every two weeks and analyzed for EPA and DHA in different lipid types. Additionally, participants will complete a food frequency questionnaire to evaluate their normal diet, sensory evaluation (overall liking, and attribute evaluation) of the beverages, and daily symptom and intake logs to track consumption and any side effects.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Yael Vodovotz, PhD; Phone Number: 614-247-7696; Email: vodovotz.1@osu.edu
• Study Contact Backup: Name: Abigail Sommer, MS; Phone Number: 317-508-7748; Email: sommer.155@osu.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Yael Vodovotz, PhD; Phone Number: 614-247-7696; Email: vodovotz.1@osu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Body mass index between 18 and 30 kg/m2

Exclusion Criteria:

• Being pregnant or nursing
• Having anemia or a condition that influences the ability to donate blood safely
• Allergies to the beverage or pill ingredients
• Diabetes
• High triglycerides or cholesterol
• Coagulation disorder
• Anticoagulation therapy or any drug that affects blood clotting.
• Taking prescribed dietary omega-3 fatty acid medications including fish oil or algae oil within the last 3 months
• Taking non-prescribed dietary omega-3 fatty acid supplements within the last 3 months and not willing to discontinue taking them for the study period
• Taking lipid lowering medications such as statins
• Sensory impairments which affect ability to taste, smell, or see food products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Algae Oil Fortified Soymilk; Subjects will drink 12 ounces of 0.4% algae oil-fortified soymilk	Other: Algae Oil Fortified Soymilk; Flavored soymilk beverage fortified with 0.4% algae oil with both EPA and DHA
Active Comparator: Algae Oil Supplements; Subjects will take 2 commercial algae oil capsules.	Dietary supplement: Algae Oil Capsule; Algae oil capsules with EPA and DHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythrocyte EPA and DHA levels	Percent EPA and DHA of total fatty acids in erythrocyte samples	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma EPA and DHA levels	Percent EPA and DHA of total fatty acids in plasma samples	4 weeks
Peripheral blood mononuclear cell (PBMC) EPA and DHA levels	Percent EPA and DHA of total fatty acids in PBMC samples	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Percent of days that participants consume their beverage or pill	4 weeks

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Yael Vodovotz, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): July 10, 2024
• Study Completion (Estimated): July 10, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Omega-3 Fatty Acids; Algae Oil; EPA and DHA
• Other Study ID Numbers: OSU-87

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No